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Title: Initial Findings Show Good Safety Record for Radiochemotherapy and Pulsed Dose Rate Brachytherapy in Cervix Carcinoma: Presented at ICACT

"Initial Findings Show Good Safety Record for Radiochemotherapy and Pulsed Dose Rate Brachytherapy in Cervix Carcinoma: Presented at ICACT"

By Chris Berrie PARIS, FRANCE -- February 2, 2005 -- Pulsed dose rate (PDR) brachytherapy can provide equivalent efficacy and safety as standard brachytherapy while also providing the radiobiological advantages of low dose rate and the physical benefits of dose optimisation in the management of carcinoma of the cervix. Olimpia Olszyk, who is just completing her MD with Dr. Eric Lartigau, MD, PhD, Professor of Radiology, Department of Radiation Therapy, Oscar Lambret Centre, Lille, France, reported the findings from 24 weeks of follow-up in a retrospective study at the 16th International Conference on Anti-Cancer Treatment. During her presentation here on February 1[^st, Ms. Olszyk said that brachytherapy is indicated before or after surgery, according to the tumour stage, or it can be a part of external beam radiation therapy. To determine the radiobiological and physical benefits of PDR brachytherapy, her team of researchers enrolled 128 women with cervical cancer (median age, 50 years; range, 29-92 years).

Their histology showed mainly squamous cell carcinoma (84%) and adenocarcinoma (12%). Most had clinical staging IB2 or greater (73%), magnetic resonance imaging at diagnosis (75%), and surgical node staging (75%) according to the researchers protocol. Pelvic node and para-aortic staging were seen in 62% and 47%, respectively.

Twenty-eight patients received PDR brachytherapy and surgery, while 76 patients received concurrent radiochemotherapy and PDR, and 24 patients received external beam radiation and PDR.

The researchers performed external beam radiation therapy to the pelvis in 77% of the women. The 4-field technique was used in most 84% of women and the median dose was 48 Gy. The pelvis sidewalls were boosted in 75% of patients, with a median dose of 7.75 Gy. Para-aortic external beam radiation was performed in 10% of women, at a median dose of 45 Gy. Among women given concurrent radiochemotherapy, 92% had 40 mg/m² of cisplatin IV weekly for a median of 6 cycles (range, 1-7).

For the PDR parameters, only intracavitary brachytherapy was performed; a Fletcher applicator was used in 8.5% of women and an individual mould in 85% of women. The median of the iridium-192 source activity was 0.26 Ci, with a mean dose rate of 0.5 Gy/hour. The medians of the mean rectal and bladder dose rates were 0.30 Gy/hour and 0.39 Gy/hour, respectively.

There were only 2 dose interruptions in each of the 3 PDR treatment groups, Ms. Olszyk noted.

With a median follow-up of 24 months, the overall 3-year disease-free and overall survivals were 64% and 66%, respectively, with these also reported for the three treatment groups as: PDR plus surgery, 92% and 96%; concurrent radiochemotherapy and PDR, 63% and 70%; radiotherapy plus PDR, 45% and 41%, respectively. The locoregional, para-aortic and metastatic recurrences were 16%, 5% and 13%, respectively.

Acute complications during PDR brachytherapy were seen in 4% of patients, with two thromboembolic complications, one mould migration, one haemorrhage and one uterus perforation.

Using the Franco-Italian glossary of Chassagne, the researchers determined that the most common complication was vaginal synecchia, which was seen in 34 of the women, although it reached grade 3 in only two of the women. Similarly, the majority of the complications were grade 1 or 2, with grade 4 bowel toxicity observed in only one case.

The researchers concluded that although the follow-up remains relatively short, the advantages of low dose rate radiobiology and the physical benefits of dose optimisation contribute to making PDR brachytherapy a safe technique that has only moderate toxicity.

[Study Title: Radiochemotherapy and Pulsed Dose Rate Brachytherapy in the Management of the Cervix Carcinoma.]

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